MGC018 With or Without MGA012 in Advanced Solid Tumors | NCT03729596 | Trialant
NCT03729596
Sponsor
MacroGenics
Status
Terminated
Last Update Posted
Jul 31, 2025Actual
Enrollment
143Actual
Phase
Phase 1Phase 2
Conditions
Squamous Cell Carcinoma of Head and Neck
Triple Negative Breast Cancer
Melanoma
Advanced Solid Tumor, Adult
Metastatic Castrate Resistant Prostate Cancer
Non Small Cell Lung Cancer
Interventions
vobramitamab duocarmazine
Countries
United States
Australia
Poland
Spain
Protocol Section
Identification Module
NCT ID
NCT03729596
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CP-MGC018-01
Secondary IDs
Not provided
Brief Title
MGC018 With or Without MGA012 in Advanced Solid Tumors
Official Title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of MGC018 (Anti-B7-H3 Antibody Drug Conjugate) Alone and in Combination With MGA012 (Anti-PD-1 Antibody) in Patients With Advanced Solid Tumors
Acronym
Not provided
Organization
MacroGenicsINDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Business decision
Expanded Access Info
No
Start Date
Nov 21, 2018Actual
Primary Completion Date
Mar 18, 2023Actual
Completion Date
Mar 18, 2023Actual
First Submitted Date
Oct 30, 2018
First Submission Date that Met QC Criteria
Oct 31, 2018
First Posted Date
Nov 2, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Oct 30, 2024
Results First Submitted that Met QC Criteria
Jul 10, 2025
Results First Posted Date
Jul 31, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jul 10, 2025
Last Update Posted Date
Jul 31, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MacroGenicsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics (PK) pharmacodynamics and preliminary antitumor activity of vobramitamab duocarmazine (MGC018) in patients with advanced solid tumors. Patients with solid tumors will be enrolled in the Dose Escalation Phase; Cohort Expansion will include metastatic castrate-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), squamous cell carcinoma of the head and neck (SCCHN), and melanoma. Patients who do not experience unacceptable toxicity or meet criteria for permanent discontinuation may undergo additional cycles for up to two years. Patients in Cohort Expansion will be followed for survival every 3 months for 2 years following last dose.
Detailed Description
Not provided
Conditions Module
Conditions
Squamous Cell Carcinoma of Head and Neck
Triple Negative Breast Cancer
Melanoma
Advanced Solid Tumor, Adult
Metastatic Castrate Resistant Prostate Cancer
Non Small Cell Lung Cancer
Keywords
antibody-drug conjugate (ADC)
B7-H3
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
143Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1
Experimental
0.5 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Cohort 2
Experimental
1.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Cohort 3
Experimental
2.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Cohort 4
Experimental
3.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Cohort 5
Experimental
4.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
mCRPC expansion
Experimental
3.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
vobramitamab duocarmazine
Biological
Anti-B7H3 antibody drug conjugate
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Patients With Adverse Events of Vobramitamab Duocarmazine as Assessed by CTCAE v4.03
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Throughout the study up to 24 months
Number of Participants With Dose Limiting Toxicities (DLT)
Number of participants with severe side effects from study treatment during the DLT evaluation period (6 weels)
up to 42 days from first dose
Secondary Outcomes
Measure
Description
Time Frame
Best Overall Response (BOR) of Vobramitamab Duocarmazine
The best response recorded from the start of the study treatment until the end of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, taking into account any requirement for confirmation of response.
Complete response (CR) is defined as disappearance of all target and non-target lesions.
Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions.
Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of non-target lesions, or appearance of new lesions.
Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progression.
Not evaluable (NE) is where the response cannot be determined.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Tissue specimen available for retrospective analysis of B7-H3 and PD-L1 expression.
Eastern Cooperative Oncology Group performance status of ≤2
Life expectancy ≥ 12 weeks for dose escalation phase and ≥ 24 weeks for cohort expansion phase
Measurable disease. Prostate cancer patients with bone only disease are eligible.
Acceptable laboratory parameters and adequate organ reserve.
Dose Escalation Phase: Patients with histologically proven, unresectable, locally advanced or metastatic solid tumors for whom no therapy with demonstrated clinical benefit is available.
Module A Cohort Expansion:
mCRPC that has progressed with one prior line of chemotherapy for metastatic disease and no more than two prior lines of anti-hormonal therapy.
NSCLC: metastatic disease after standard cytotoxic, targeted, and biologic or checkpoint inhibitor therapy. No more than 2 prior lines of chemotherapy.
TNBC: Locally advance or metastatic disease that has progressed following at least one systemic therapy.
SCCHN that has progressed during or following at least one systemic therapy for metastatic or recurrent unresectable disease. No more than 2 prior lines of chemotherapy.
Melanoma that has progressed during or following at least one systemic treatment for unresectable locally advanced or metastatic disease. Patients who are intolerant of or refused standard therapy are eligible.
Exclusion Criteria:
Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on MRI, CT or PET within 6 months, or history of leptomeningeal disease or cord compression at the time of enrollment.
Prior treatment with B7-H3 targeted agents for cancer.
Treatment with systemic cancer therapy, biologic agents, or anti-hormonal therapy (mCRPC) within 4 weeks, prior small molecule targeted or kinase inhibitors within 14 days or 5 half-lives, prior radioligand within 6 months
Clinically significant cardiovascular disease.
Clinically significant pulmonary compromise or requirement for supplemental oxygen.
History of clinically-significant cardiovascular disease, including but not limited to pericarditis or pericardial effusion.
Active viral (including confirmed or presumed COVID-19), bacterial, or systemic fungal infection requiring parenteral treatment within 7 days of first study drug administration.
Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.
Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.
Major trauma or major surgery within 4 weeks of first study drug administration.
Clinically significant venous insufficiency.
> Grade 1 peripheral neuropathy.
Evidence of pleural effusion.
Evidence of ascites.
Serum testosterone >50 ng/dl or >1.7 nmol/L in mCRPC in Module A Cohort Expansion Phase
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ashley Ward, M.D.
MacroGenics
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCLA Department of Medicine - Hematology/Oncology
Santa Monica
California
90404
United States
Sibley Memorial Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Module B of the study was never initiated. There were no participants enrolled.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1
0.5 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG001
Cohort 2
1.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Aug 16, 2021
Oct 16, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Dose escalation will use a 3+3+3 design to identify an MAD or MTD, followed by a Cohort Expansion.
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
NSCLC expansion
Experimental
3.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
TNBC expansion
Experimental
3.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Melanoma expansion
Experimental
3.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
SCCHN expansion
Experimental
3.0 mg/kg IV every 3 weeks
Biological: vobramitamab duocarmazine
Melanoma expansion
NSCLC expansion
SCCHN expansion
TNBC expansion
mCRPC expansion
MGC018
Throughout the study for up to 24 months
Objective Response Rate (ORR) of Vobramitamab Duocarmazine
The percentage of participants who achieve a complete response (CR or partial response (PR) to treatment with vobramitamab duocarmazine
Efficacy evaluations every 9 weeks throughout the study for up to 24 months
Progression Free Survival (PFS) of Vobramitamab Duocarmazine
PFS is calculated from the first dose date until the date of first documented PD using RECIST v1.1, or death from any cause, whichever occurs first.
Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of non-target lesions, or appearance of new lesions. Median PFS and 95% CI is estimated using the Kaplan-Meier method.
Every 9 weeks for up to 24 months
Median Duration of Response (DoR) of Vobramitamab Duocarmazine
Median DoR assessed as the time from the date of initial objective response to the date of first documented PD, per RECIST v1.1, or the date of death from any cause, whichever occurs first.
Median DoR and 95% CI is estimated using the Kaplan-Meier method.
Throughout the study for up to 48 months
Median Overall Survival (OS) of Vobramitamab Duocarmazine
Median OS assessed as the time from the first dose date to the date of death from any cause, using the Kaplan-Meier method for estimating median and confidence interval. .
Every 9 weeks for up to 24 months
PSA Response Rate
Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA) with confirmation at least 3 weeks later
Every 3 weeks up to 24 months
Best PSA Response
For prostate cancer patients, the greatest change from baseline in PSA.
Every 3 weeks up to 24 months
Mean Area Under the Curve (AUC) of Vobramitamab Duocarmazine Antibody Drug Conjugate (ADC)
Area under the plasma concentration versus time curve of vobramitamab duocarmazine
At baseline, Cycle 1, Day 1: 1 hour, 4 hours after the first dose, Day 2, Day 3, Day 7, Day 14 and Cycle 2 Day 1 (approximately 21 days after the first dose).
Mean AUC of Duocarmycin
Area under the plasma concentration versus time curve of duocarmycin (unconjugated payload) in the bloodstream
At baseline, Cycle 1, Day 1: 1 hour, 4 hours after the first dose, Day 2, Day 3, Day 7, Day 14 and Cycle 2 Day 1 (approximately 21 days after the first dose).
Mean Maximum Concentration Vobramitamab Duocarmazine ADC
Maximum Plasma Concentration of vobramitamab duocarmazine ADC in the bloodstream
At baseline, Cycle 1, Day 1, 1 and 4 hours after the end of infusion, Day 2, and Day 3.
Mean Maximum Concentration Duocarmycin
Maximum Plasma Concentration of vobramitamab duocarmazine ADC in the bloodstream
At baseline, Cycle 1, Day 1, 1 and 4 hours after the end of infusion, Day 2, and Day 3.
Mean Trough Concentration of Vobramitamab Duocarmazine ADC
Average trough plasma concentration of vobramitamab duocarmazine ADC in the bloodstream.
At baseline, and before subsequent infusion Cycle 2, Day 1 (Study Day 22).
Mean Trough Concentration of Duocarmycin
Average trough plasma concentration of duocarmycin unconjugated payload in the bloodstream.
At baseline, and before subsequent infusion Cycle 2, Day 1 (Study Day 22).
Number of Participants Who Develop MGC018 Anti-drug Antibodies
Shifts in MGC018 anti-drug antibodies after treatment with vobramitamab duocarmazine
Every 3 weeks through end of treatment, up to 24 months
Washington D.C.
District of Columbia
20016
United States
The Johns Hopkins Kimmel Cancer Center
Baltimore
Maryland
21231
United States
START Midwest
Grand Rapids
Michigan
49546
United States
Nebraska Methodist Hospital
Omaha
Nebraska
68114
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89169
United States
Carolina Biooncology Institute
Huntersville
North Carolina
28078
United States
Inova Schar Cancer Institute
Fairfax
Virginia
22031
United States
Virginia Cancer Specialist
Fairfax
Virginia
22031
United States
St Vincent's Health Network (Kinghorn Cancer Centre)
Darlinghurst
2010
Australia
Austin Health - Olivia Newton John Cancer Center
Heidelberg
3084
Australia
Calvary Mater NewCastle
Waratah
2298
Australia
The University of Queensland - Princess Alexandra Hospital (PAH)
Woolloongabba
4105
Australia
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie Oddział Kliniczny Onkologii
Krakow
31-501
Poland
Med-Polonia Sp. z o.o.
Poznan
60-693
Poland
Magodent Sp. z o.o. Szpital Elbląska Oddział Onkologii Klinicznej/ Chemioterapii
Warsaw
01-748
Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Oddział Badań Wczesnych Faz
Warsaw
02-781
Poland
Hospital Universitario Vall d'Hebron
Barcelona
08035
Spain
Institut Català D'Oncologia - Hospital Universitari Germans Trias I Pujol
Barcelona
Spain
Hospital Universitario HM Sanchinarro
Madrid
20850
Spain
Hospital Ruber Internacional
Madrid
28034
Spain
FG002
Cohort 3
2.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG003
Cohort 4
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG004
Cohort 5
4.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG005
mCRPC Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG006
NSCLC Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG007
TNBC Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG008
Melanoma Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG009
SCCHN Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
FG0003 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0046 subjects
FG00541 subjects
FG00621 subjects
FG00718 subjects
FG00821 subjects
FG00913 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0027 subjects
FG0037 subjects
FG0046 subjects
FG00541 subjects
FG00621 subjects
FG00718 subjects
FG00821 subjects
FG00913 subjects
Type
Comment
Reasons
Death
FG0003 subjects
FG0015 subjects
FG0024 subjects
FG0031 subjects
FG0040 subjects
FG00534 subjects
FG00618 subjects
FG00714 subjects
FG00819 subjects
FG0099 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
protocol amendment
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0036 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
study terminated by sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1
0.5 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG001
Cohort 2
1.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG002
Cohort 3
2.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG003
Cohort 4
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG004
Cohort 5
4.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG005
mCRPC Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG006
NSCLC Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG007
TNBC Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG008
Melanoma Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG009
SCCHN Expansion
3.0 mg/kg IV every 3 weeks
vobramitamab duocarmazine: Anti-B7H3 antibody drug conjugate
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0003
BG0016
BG0027
BG0037
BG0046
BG00541
BG00621
BG00718
BG00821
BG00913
BG010143
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.3± 12.42
BG00156.5± 11.98
BG00264.0± 11.72
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0014
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Black or African American
Title
Measurements
BG0000
BG0013
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0003
BG0016
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Patients With Adverse Events of Vobramitamab Duocarmazine as Assessed by CTCAE v4.03
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Posted
Count of Participants
Participants
Throughout the study up to 24 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
4.0 mg/kg IV every 3 weeks
OG005
mCRPC Expansion
3.0 mg/kg IV every 3 weeks
OG006
NSCLC Expansion
3.0 mg/kg IV every 3 weeks
OG007
TNBC Expansion
3.0 mg/kg IV every 3 weeks
OG008
Melanoma Expansion
3.0 mg/kg IV every 3 weeks
OG009
SCCHN Expansion
3.0 mg/kg IV every 3 weeks
Units
Counts
Participants
OG0003
OG0016
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0003
OG0016
OG0027
OG003
Primary
Number of Participants With Dose Limiting Toxicities (DLT)
Number of participants with severe side effects from study treatment during the DLT evaluation period (6 weels)
Posted
Count of Participants
Participants
up to 42 days from first dose
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
4.0 mg/kg IV every 3 weeks
Secondary
Best Overall Response (BOR) of Vobramitamab Duocarmazine
The best response recorded from the start of the study treatment until the end of treatment according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1, taking into account any requirement for confirmation of response.
Complete response (CR) is defined as disappearance of all target and non-target lesions.
Partial response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions, and no new lesions.
Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of non-target lesions, or appearance of new lesions.
Stable disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progression.
Not evaluable (NE) is where the response cannot be determined.
All participants who received at least one dose of study drug, had baseline measurable or non-measurable disease, and had at least one post-baseline radiographic tumor assessment or discontinued treatment due to clinical progressive disease or death.
Posted
Count of Participants
Participants
Throughout the study for up to 24 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
Secondary
Objective Response Rate (ORR) of Vobramitamab Duocarmazine
The percentage of participants who achieve a complete response (CR or partial response (PR) to treatment with vobramitamab duocarmazine
Posted
Number
95% Confidence Interval
percentage of participants
Efficacy evaluations every 9 weeks throughout the study for up to 24 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
4.0 mg/kg IV every 3 weeks
OG005
mCRPC Expansion
Secondary
Progression Free Survival (PFS) of Vobramitamab Duocarmazine
PFS is calculated from the first dose date until the date of first documented PD using RECIST v1.1, or death from any cause, whichever occurs first.
Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, or unequivocal progression of non-target lesions, or appearance of new lesions. Median PFS and 95% CI is estimated using the Kaplan-Meier method.
Posted
Median
95% Confidence Interval
months
Every 9 weeks for up to 24 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
Secondary
Median Duration of Response (DoR) of Vobramitamab Duocarmazine
Median DoR assessed as the time from the date of initial objective response to the date of first documented PD, per RECIST v1.1, or the date of death from any cause, whichever occurs first.
Median DoR and 95% CI is estimated using the Kaplan-Meier method.
Participants who experienced a complete or partial response to study treatment.
Posted
Median
95% Confidence Interval
months
Throughout the study for up to 48 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
Secondary
Median Overall Survival (OS) of Vobramitamab Duocarmazine
Median OS assessed as the time from the first dose date to the date of death from any cause, using the Kaplan-Meier method for estimating median and confidence interval. .
Posted
Median
95% Confidence Interval
months
Every 9 weeks for up to 24 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
4.0 mg/kg IV every 3 weeks
OG005
mCRPC Expansion
Secondary
PSA Response Rate
Percent of prostate cancer patients with at least 50% reduction in prostate-specific antigen (PSA) with confirmation at least 3 weeks later
Posted
Count of Participants
Participants
Every 3 weeks up to 24 months
ID
Title
Description
OG000
mCRPC
Participants in cohort expansion with metastatic castration-resistant prostate cancer.
Units
Counts
Participants
OG00041
Title
Secondary
Best PSA Response
For prostate cancer patients, the greatest change from baseline in PSA.
Posted
Mean
Standard Deviation
ng/mL
Every 3 weeks up to 24 months
ID
Title
Description
OG000
mCRPC
Participants in cohort expansion with metastatic castration-resistant prostate cancer.
Units
Counts
Participants
OG00041
Title
Denominators
Categories
Secondary
Mean Area Under the Curve (AUC) of Vobramitamab Duocarmazine Antibody Drug Conjugate (ADC)
Area under the plasma concentration versus time curve of vobramitamab duocarmazine
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. One participant assigned to Cohort 4 (3.0 mg/kg dose) was actually treated at the Cohort 3 dose of 2.0 mg/kg and is therefore included in Cohort 3 for the purposes of this analysis.
Posted
Mean
Standard Deviation
mcg/mL*day
At baseline, Cycle 1, Day 1: 1 hour, 4 hours after the first dose, Day 2, Day 3, Day 7, Day 14 and Cycle 2 Day 1 (approximately 21 days after the first dose).
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
Secondary
Mean AUC of Duocarmycin
Area under the plasma concentration versus time curve of duocarmycin (unconjugated payload) in the bloodstream
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. One participant assigned to Cohort 4 (3.0 mg/kg dose) was actually treated at the Cohort 3 dose of 2.0 mg/kg and is therefore included in Cohort 3 for the purposes of this analysis.
Posted
Mean
Standard Deviation
ng/mL*day
At baseline, Cycle 1, Day 1: 1 hour, 4 hours after the first dose, Day 2, Day 3, Day 7, Day 14 and Cycle 2 Day 1 (approximately 21 days after the first dose).
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
Secondary
Mean Maximum Concentration Vobramitamab Duocarmazine ADC
Maximum Plasma Concentration of vobramitamab duocarmazine ADC in the bloodstream
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. One participant assigned to Cohort 4 (3.0 mg/kg dose) was actually treated at the Cohort 3 dose of 2.0 mg/kg and is therefore included in Cohort 3 for the purposes of this analysis
Posted
Mean
Standard Deviation
mcg/mL
At baseline, Cycle 1, Day 1, 1 and 4 hours after the end of infusion, Day 2, and Day 3.
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
Secondary
Mean Maximum Concentration Duocarmycin
Maximum Plasma Concentration of vobramitamab duocarmazine ADC in the bloodstream
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. One participant assigned to Cohort 4 (3.0 mg/kg dose) was actually treated at the Cohort 3 dose of 2.0 mg/kg and is therefore included in Cohort 3 for the purposes of this analysis
Posted
Mean
Standard Deviation
ng/mL
At baseline, Cycle 1, Day 1, 1 and 4 hours after the end of infusion, Day 2, and Day 3.
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
Secondary
Mean Trough Concentration of Vobramitamab Duocarmazine ADC
Average trough plasma concentration of vobramitamab duocarmazine ADC in the bloodstream.
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. One participant assigned to Cohort 4 (3.0 mg/kg dose) was actually treated at the Cohort 3 dose of 2.0 mg/kg and is therefore included in Cohort 3 for the purposes of this analysis.
Posted
Mean
Standard Deviation
mcg/mL
At baseline, and before subsequent infusion Cycle 2, Day 1 (Study Day 22).
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
Secondary
Mean Trough Concentration of Duocarmycin
Average trough plasma concentration of duocarmycin unconjugated payload in the bloodstream.
All participants who received at least one dose of study treatment, date and time of dose administration and relative PK sample collection are known and have sufficient concentration data to derive the PK parameter. One participant assigned to Cohort 4 (3.0 mg/kg dose) was actually treated at the Cohort 3 dose of 2.0 mg/kg and is therefore included in Cohort 3 for the purposes of this analysis.
Posted
Mean
Standard Deviation
ng/mL
At baseline, and before subsequent infusion Cycle 2, Day 1 (Study Day 22).
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
Secondary
Number of Participants Who Develop MGC018 Anti-drug Antibodies
Shifts in MGC018 anti-drug antibodies after treatment with vobramitamab duocarmazine
All participants who received at least one dose of study treatment and have at least one ADA sample sufficient for analysis. There were 3 missing samples.
Posted
Count of Participants
Participants
Every 3 weeks through end of treatment, up to 24 months
ID
Title
Description
OG000
Cohort 1
0.5 mg/kg IV every 3 weeks
OG001
Cohort 2
1.0 mg/kg IV every 3 weeks
OG002
Cohort 3
2.0 mg/kg IV every 3 weeks
OG003
Cohort 4
3.0 mg/kg IV every 3 weeks
OG004
Cohort 5
4.0 mg/kg IV every 3 weeks
Time Frame
Adverse events were collected for each participant from the time of first dose through 28 days after the last dose of study treatment or until the start of another anti-cancer treatment, up to 25 months. All cause mortality was assessed from the time of first dose until death, or participant withdrawal of consent, or the end of the study, whichever was earlier, up to 25 months.
Description
Adverse events are based on physical findings, patient reports, and significant laboratory values.
Progression of neoplasm causing hospitalization or death is an antitumor activity outcome and not an SAE, unless considered drug-related by the investigator.